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Clinical Trial to Evaluate the Effect and Safety of MSV in Xerostomy

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ClinicalTrials.gov Identifier: NCT03743155
Recruitment Status : Not yet recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Institut de Terapia Regenerativa Tissular

Brief Summary:
Phase II not controlled, open-label, prospective, single center clinical trial

Condition or disease Intervention/treatment Phase
Xerostomia Due to Radiotherapy Biological: mesenchymal cells Phase 2

Detailed Description:
  • Determine changes in the xerostomia characteristics and discomfort degree by means of questionnaires addressed to the physician and subject of study.
  • Determine the volume of submaxilar saliva without stimulation and with stimulation by sialometry (SL).
  • Detect changes in volume, vascularization and fibrosis of submaxillary glands based on magnetic resonance imaging (MRI) with contrast.
  • Detect changes of submaxillary gland functionalism based on Gammagraphy (GF).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: single arm due to not alternative treatment exist
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial to Evaluate the Effect and Safety of MSV * in Xerostomia * Adult Autologous Bone Marrow Mesenchymal Stem Cells, Expanded Under GMP of IBGM
Estimated Study Start Date : December 15, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

Arm Intervention/treatment
Experimental: treatment with mesenchymal stem cells
xerostomy using mesenchymal stem cells adult autologous bone marrow
Biological: mesenchymal cells
Autologous bone marrow aspiration is used as a cellular source to obtain MSVs and is subjected to the protocolized anticoagulant procedure. After checking the perfect condition of the shipment and the correct completion of the documentation that accompanies it, the processing of the bone marrow will be carried out. The processing of the bone marrow will be done in the Cell Therapy Unit of the IBGM under NCF, within 24 hours of the completion of the aspiration




Primary Outcome Measures :
  1. Changes in the characteristics and degree of discomfort of xerostomia trough OHIP questionnaire [ Time Frame: 24 months ]
    Absolute and relative change of the score of the OHIP Questionnaire (OHIP-14-sp)

  2. Changes in the characteristics and degree of discomfort of xerostomia. [ Time Frame: 24 months ]
    Absolute and relative change of the score of the EVA Questionnaire

  3. Sialometry results [ Time Frame: 24 months ]
    Absolute and relative change in the volume of saliva (ml / min) submaxillary

  4. Restoration of the glandular structure. [ Time Frame: 24 months ]
    Changes in the glandular structure (volume) (MRI with contrast)

  5. Restoration of the glandular structure. [ Time Frame: 24 months ]
    Changes in the glandular structure (vascularization) (MRI with contrast)

  6. Restoration of the glandular structure. [ Time Frame: 24 months ]
    Changes in the glandular structure (fibrosis of submaxillary glands) (MRI with contrast)

  7. Measurement of submaxillary gland functionalism changes based on Gammagraphy [ Time Frame: 24 months ]
    Measurement of submaxillary gland functionalism changes based on Gammagraphy


Secondary Outcome Measures :
  1. AEs and SAEs [ Time Frame: 24 months ]
    Determination of the Safety of the proposed procedure, recording adverse events (AEs) and serious adverse events (SAEs). It will be considered as early safety measures: Pain at the site of injection, submaxillary swelling, duration of submaxillary swelling in days, oral discomfort, infection



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients from 18 to 75 years old of both sexes.
  2. Biochemical analysis without significant alterations which could contraindicate the treatment.
  3. Bilateral radiotherapy of the previous neck due to neoplasia in states T1-T2 and N0, N1 and N2a.
  4. 2 years of follow-up without recurrence.
  5. Reduction of salivation and hyposalivation, evaluated by an examination, flow rate or whole unstimulated saliva in the range of 0.05- 0.20 ml / min.
  6. Grade 1-3 xerostomy as assessed by the grading scale.
  7. The patient is able to understand the nature of the study.
  8. Written informed consent of the patient

Exclusion Criteria:

  1. Participation in another clinical trial in the 3 months prior to his/her inclusion.
  2. Present infection (no infectious sign should be evidenced with repercussion on the evolution of the treated lesion).
  3. Patients with positive serologies for HIV, lues and hepatitis with positive viral load.
  4. History of cancer in the last 2 years. History of teratoma, adenocarcinoma derived from one of the salivary glands, lymphoma of the tonsils or some other lymphatic tissue or melanoma of pigmented cells of the oral mucosa.
  5. Xerogenic medication in progress.
  6. Other diseases of the salivary glands, for example, Sjögren's syndrome, sialolithiasis, etc.
  7. Local infection.
  8. Pregnancy or pregnancy planned within the next 2 years.
  9. Breastfeeding.
  10. Treatment with anticoagulants (not interruptible in MO or application).
  11. Any other illness or condition that is grounds for exclusion for the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743155


Contacts
Contact: Lluis Orozco, MD 600 421 095 lluis.orozco@itrt.es
Contact: Roberto Soler Rich, MD 609 525 263 robert.soler@itrt.es

Locations
Spain
Institut de Terapia Regenerativa Tissular
Barcelona, Spain, 08022
Sponsors and Collaborators
Institut de Terapia Regenerativa Tissular

Responsible Party: Institut de Terapia Regenerativa Tissular
ClinicalTrials.gov Identifier: NCT03743155     History of Changes
Other Study ID Numbers: XRS-ITRT-2018
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases